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The hip prosthesis MiniMAX is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.

· Avascular necrosis of the femoral head.

· Acute traumatic fracture of the femoral head or neck.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

MiniMax anatomical stems are coated cementless stems intended to be used in total or partial hip arthroplasty in primary or revision surgery.

The anatomical design of the MiniMax stems results in a 9° anteversion of the neck which is mirror polished with 12/14 Eurocone taper and a 127° neck-shaft angle. The macrostructures are negative medially and positive laterally which increases the contact area. The lateral flare is rounded and non-invasive. The MiniMAX stems' distal tip has a 5° curvature to follow the contours of the femoral canal to aid in the insertion and avoiding distal interference.

MiniMAX stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

MiniMAX stems are made of Titanium Aluminum Niobium Alloy (Ti-6Al-7Nb). The surface treatment consists of titanium plasma spray coating, Ra 300um, in the proximal 2/3 of the shaft to improve proximal fixation and HA (Hydroxyapatite) coating, Ra 80um, along the entire length of the shaft.

This submission seeks add Size 9 left and right anatomical stems to the currently marketed MiniMAX product line.

The provided text describes a 510(k) premarket notification for a medical device (MiniMAX hip prosthesis) and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The document is a traditional medical device submission focused on substantial equivalence to a predicate device, primarily through mechanical testing and material characterization.

Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies for an AI/ML device is not present in the provided text.

However, I can extract the information that is present regarding the device's performance data and how it was evaluated.

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with numerical targets and reported performance for an AI/ML device. Instead, it lists the types of performance tests conducted for a mechanical hip prosthesis and states that the "subject devices do not represent a new worst case when compared to the previously cleared devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "worst-case device" testing for the predicate device, K170845. This typically implies a very small sample size, potentially N=1 or N=3, for each test as per engineering standards for mechanical devices. It's not a 'test set' in the sense of an AI/ML validation. There's no information on data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a mechanical device submission, not an AI/ML study requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a mechanical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" is defined by the passing criteria of the specified international standards (e.g., ISO, ASTM). For example, fatigue tests would have an endurance limit or cycles to failure requirement specified in the standard.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable.

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The hip prosthesis MiniMAX is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Hip Replacement is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.

· Avascular necrosis of the femoral head.

· Acute traumatic fracture of the femoral head or neck.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The purpose of this submission is to gain clearance for the new MiniMAX, which are anatomical HA coated cementless stems intended to be used in total or partial hip arthroplasty in primary or revision surgery.

The anatomical design of the MiniMAX stems results in a 9° anteversion of the neck which is mirror polished with 12/14 Eurocone taper and a 127° neck-shaft angle. The macrostructures are negative medially and positive laterally which increases the contact area. The lateral flare is rounded and non-invasive. The MiniMAX stems' distal tip have a 5° curvature to follow the contours of the femoral canal to aid in the insertion and avoiding distal interference.

MiniMAX stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

MiniMAX stems are made of Titanium Aluminum Niobium Alloy (Ti-6Al-7Nb). The surface treatment consists of titanium plasma spray coating, Ra 300μm, in the proximal 2/3 of the shaft to improve proximal fixation and HA (Hydroxyapatite) coating, Ra 80um, along the entire length of the shaft.

MiniMAX stems are similar to predicate devices Howmedica Osteonics' ABG III Monolithic Hip Stem (K123604) and Medacta's MasterLoc Stem (K151531).

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not explicitly stated in the provided document. The document mentions "testing was conducted to written protocols," but does not detail the number of units tested for each mechanical or coating test.
• Data provenance:
  • Country of origin: Not specified beyond the manufacturer being Medacta International SA (Switzerland). The testing standards are international (ISO, ASTM, European Pharmacopoeia, USP).
  • Retrospective or Prospective: Not applicable in this context as these are laboratory-based non-clinical performance and material tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. The "ground truth" for non-clinical performance tests is established by adhering to widely recognized engineering and medical device standards (ISO, ASTM, EN, USP, European Pharmacopoeia) and internal protocols. These tests measure objective properties (e.g., fatigue strength, range of motion, coating characteristics) rather than requiring expert interpretation of clinical data as a "ground truth."

4. Adjudication method for the test set

• Not applicable. This concept typically applies to clinical studies where different readers or experts might have varying interpretations. For non-clinical, objective testing, results are measured against predefined acceptance criteria from established standards. There is no "adjudication" in the sense of reconciling differing expert opinions on the test outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This is a medical device (hip prosthesis), not an AI-based diagnostic or assistive software. The submission focuses on the safety and effectiveness of the implant itself through material properties and mechanical performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No, a standalone (algorithm only) performance study was not done. This is a hardware medical device, not a software algorithm.

7. The type of ground truth used

• The "ground truth" for the performance data in this submission is based on established international and national standards (e.g., ISO 7206 series for hip prostheses, ASTM F2009 for taper connections, EN ISO 21535 for hip-joint implants, European Pharmacopoeia and USP for pyrogenicity). These standards define the acceptable performance parameters and testing methodologies for such devices.

8. The sample size for the training set

• Not applicable. This submission describes a physical medical device. There is no "training set" in the context of an algorithm or machine learning model. The relevant "data" for development would involve extensive engineering design, material science data, and prior knowledge from similar predicate devices.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set in the AI/ML sense, there is no ground truth established for a training set. The device design and manufacturing process would be informed by decades of biomechanical research, clinical outcomes with similar devices, and engineering principles. The "ground truth" for its design and manufacturing would be validated through the performance testing described.

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"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma.

"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR)

The provided text is a 510(k) clearance letter from the FDA for a medical device called "miniMAX" Peak Flow Meter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given text.

The document primarily focuses on:

• The FDA's decision of substantial equivalence for the "miniMAX" Peak Flow Meter.
• The regulatory classification of the device (Class II).
• General controls and potential additional controls applicable to the device.
• Contact information for further regulatory inquiries.
• The intended use of the device: "measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma."

To answer your questions, I would need a different document, such as the actual 510(k) summary or the premarket notification submission itself, which would detail the performance data and testing conducted for the device.

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